WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis

NCT06946329 | Enrolling By Invitation

• 1 other identifier: 9378-1403
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT evaluates whether WATERinMOTION aquatic therapy improves pain, function, and quality of life more effectively than land-based exercise in obese men with knee osteoarthritis (OA). We will assess clinical outcomes (WOMAC), serum biomarkers (COMP, IL-6), and real-world activity (accelerometry) at baseline, 8 weeks, and 6 months.

Conditions

Osteoarthritis; Knee; Obesity

Keywords

Aquatic Therapy; Exercise Therapy; Quality of Life; Biomarkers; Wearable Electronic Devices

Outcome Measures

Primary Outcomes (2)

• WOMAC Pain Subscale

  Change from baseline in WOMAC pain score (0-20 scale).

  Baseline, 8 weeks, 6 months

• WOMAC Function Subscale

  Change in functional disability (0-68 scale).

  Baseline, 8 weeks, 6 months

Secondary Outcomes (3)

• SF-36 Quality of Life

  Baseline, 8 weeks, 6 months

• Serum COMP

  Baseline, 8 weeks

• Daily Step Count

  Continuous over 8 weeks

Study Arms (2)

Aquatic Exercise

EXPERIMENTAL

Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.

Behavioral: Aquatic Exercise

Land-Based Rehabilitation

ACTIVE COMPARATOR

Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.

Behavioral: Land-Based Rehabilitation

Interventions

Aquatic Exercise BEHAVIORAL

Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.

Aquatic Exercise

Land-Based Rehabilitation BEHAVIORAL

Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.

Land-Based Rehabilitation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Males aged 45-65
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 45-65
• BMI ≥30 kg/m²
• Radiographic knee OA (Kellgren-Lawrence grade 2-3)
• WOMAC pain score ≥25/50

You may not qualify if:

• Inflammatory arthritis (e.g., rheumatoid)
• Intra-articular injections within 3 months
• Contraindications to aquatic exercise

Sponsors & Collaborators

• University of Sistan and Baluchestan: lead

Study Sites (1)

Sport Sciences Department

Zahedan, Sistan and Baluchestan, 9816744818, Iran

Location

MeSH Terms

Conditions

Osteoarthritis; Obesity

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Mohammadreza Rezaeipour, MD,PhD

  Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: May 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)